Trial Outcomes & Findings for Tofacitinib in Recurrent GBM Patients (NCT NCT05326464)

Tofacitinib in Recurrent GBM Patients

Median progression-free survival from initiation of Tofacitinib until disease progression as defined by the RANO criteria, unacceptable toxicity, withdrawal of consent, or discontinuation from the trial for any other reason.

Median OS of the study patients from time of study entry until death or lost to follow-up.

Assess safety and tolerability associated with Tofacitinib 5 mg orally twice daily when administered to GBM patients. NCI Common terminology criteria for adverse events (CTCAE v.5) will be used to assess the adverse events.

Tumor response will be assessed using contrast and non-contrast brain magnetic resonance imaging (MRI) with assessments based on the international criteria proposed by the Response Assessment in Neuro-Oncology (RANO) Working Group, until progression of disease. For patients who do not progress or die, PFS will be censored at the last adequate radiologic assessment. RANO criteria: Complete Response (CR): Complete disappearance of all enhancing measurable and non measurable disease sustained for at least 4 weeks; Partial Response (PR): ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; Progressive Disease (PD): ≥25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids;